Cleared Traditional

K051368 - BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM

K051368 is an FDA 510(k) clearance for BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM, manufactured by Schiller AG. The device is a Class 2 Cardiovascular device with product code DXN cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K051368 · Schiller AG · Cardiovascular device
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Aug 2005
Decision
76d
Days
Class 2
Risk

K051368 is an FDA 510(k) clearance for the BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM. Classified as System, Measurement, Blood-pressure, Non-invasive (product code DXN), Class II - Special Controls.

Submitted by Schiller AG (Baar, CH). The FDA issued a Cleared decision on August 9, 2005 after a review of 76 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1130 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Schiller AG devices

FDA 510(k) Submission Details - K051368

510(k) Number K051368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2005
Decision Date August 09, 2005
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXN Device Classification - Class 2, Special Controls

Product Code DXN System, Measurement, Blood-pressure, Non-invasive
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1130
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXN System, Measurement, Blood-pressure, Non-invasive

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